Effectiveness of Second‐ and Third‐Generation Immunoassays for the Detection of Hepatitis C Virus Infection in Pregnant Women

Objective: To compare the sensitivity and specificity of a third‐generation anti‐hepatitis C virus (anti‐HCV) assay (HCV 3.0) with second‐generation one (HCV 2.0), and correlate with HCV‐RNA positivity by reverse‐transcription polymerase chain reaction (RT‐PCR). Methods: We enrolled 197 pregnant women without screening for alanine aminotransferase (ALT) (Group A) and 324 pregnant women with elevated ALT activity (> 45 IU/ l ) (Group B). Each serum sample was tested by second‐ and third‐generation tests, and anti‐HCV titer was determined by serial dilutions. Anti‐HCV‐positive samples were subjected to HCV‐RNA assays. Results: Three (1.5%) and 4 (2.0%) of the 197 group A subjects were anti‐HCV‐positive by the second‐ and third‐generation methods, respectively, while 17 (5.3%) and 21 (6.5%) of group B were positive, respectively. Three (1.5%) in group A and 8 (2.5%) in group B were HCV 2.0‐negative, but positive for HCV 3.0. The sensitivity, specificity, positive and negative predictive values of HCV 2.0 and HVC 3.0 for positive HCV‐RNA in both groups were 67 vs 100%, 30 vs 75%, 67 vs 92%, and 30 vs 100%, respectively. The anti‐HCV‐positive samples with optical density (O.D.) < 1.0 either by second‐ or third‐generation test were negative for HCV‐RNA, whereas samples with O.D. < 1.0 were all HCV‐RNA‐positive. Conclusions: The performance of HCV 3.0 is better than that of HCV 2.0, and anti‐HCV‐positive samples with O.D. < 1.0 are negative for HCV‐RNA.